The FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) to include manufacturers of immediate-release opioids. The makers of these drugs will soon be required to provide training and education to healthcare professionals on the proper prescription and use of the drugs for pain management…
(Reuters)—The U.S. Food and Drug Administration plans to encourage opioid addicts to use less harmful opioid drugs such as methadone and buprenorphine, a radical shift in policy that could agitate those in the addiction field who believe abstinence is the only effective treatment. Speaking before the House Committee on Energy and Commerce on Wednesday, FDA…
The FDA accepted for review a supplemental biologics license application for denosumab to treat patients with glucocorticoid-induced osteoporosis…
LONDON (Reuters)—GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year. It also secured a recommendation from U.K. cost authorities for a $700,000 gene therapy for so-called “bubble boy” disease—a step forward for the field of fixing faulty…
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…
NEW YORK (Reuters)—Makers of fast-acting opioids will have to fund voluntary training for healthcare professionals who prescribe the drugs, including education on safe prescribing practices and non-opioid alternatives, the course said on Thursday. The FDA sent letters to 74 manufacturers of immediate-release opioids, notifying them that they will have to fund the development of courses…